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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
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Position Summary:
Optimizes and establishes bioanalytical methods for protein production and purification.
Performs laboratory work supporting bioanalysis and characterization of process development experiments and early-stage clinical development production/manufacturing runs.
Works with RBI's Quality Control unit supporting analytical method feasibility and phase-appropriate validation (method qualification) of release testing assays.
Authors method feasibility workplans and method qualification protocols; executes the workplans/protocols in the Development lab or in RBI's Quality Control laboratory as needed/appropriate; helps in troubleshooting any challenges during the execution; authors reports and method SOPs/WINs.
Conducts analytical testing/development work in small teams or individually as required.
Prepares comprehensive and complete documentation; conducts thorough analysis of data; reports results for all work completed.
Conducts high-quality work in accordance with all required safety standards and Regulatory guidelines where applicable.
Completes experimental work/written documents etc. in a timely manner according to project timelines.
Responsibilities:
Conducts the transfer, development, and qualification/validation of analytical methods in coordination with Quality Control and Quality Assurance, as required.
Prepares workplans, protocols, records, and reports.
Presents results, recommendations and next steps for projects to clients and management.
Prepares written reports of results, analyses, and summaries of work.
Prepares laboratory methods and procedures, SOPs/WINs and executes work at the appropriate level of compliance for non-GMP and GMP projects as required.
Coordinates external testing with vendors or other labs in the RESILIENCE network as required
Participates in project team meetings and works on multiple projects as required.
Maintains up to date technical and compliance training.
Ensures all required materials to perform work are available and maintained.
Ensures all required equipment and devices are maintained and calibrated appropriately.
Minimum Qualifications
Knowledge and/or practical experience in protein analysis such as HPLC, LC-MS, GC-MS, BCA, Bradford, ELISA, cIEF, SDS-PAGE, Western blot, and concentration analysis using UV-Vis Spectrophotometry.
Good written and verbal communication skills
Works well independently and in a team environment
Able to keep meticulous laboratory records
Preferred Qualifications
Ph.D. with
1-2 years industry experience; M.Sc. with 5 years' experience
Experience in R&D or Quality Lab environments
Experience writing experimental and/or GMP documents in accordance with departmental and company Quality Standards
Protein chemistry; protein characterization; bioanalytical methods
Hands-on experience in development and execution of bioanalytical techniques for protein therapeutics
GDP compliant analytical methods and record keeping as appropriate for R&D and GMP manufacturing
This position may also include the following conditions:
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